The Control Study for the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken.

Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) are being recruited for the Trans-MAPP Control Study. These participants will act as a reference/control group for the Trans-MAPP Epidemiology & Phenotyping (EP) Study.

As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often not helpful. The goal of this study is to better understand how pain is felt in people with IC or CP. The MAPP Control Study is an observational study that will enroll participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. The investigators will ask questions and gather information about the health and life of the participants for research purposes. The investigators hope that this study will lead to improvement in the treatment of IC and CP.

Healthy Control participants do not suffer from any Urological Chronic Pelvic Pain Syndromes or from the following conditions:

Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome

Positive Control

Positive Control participants do not suffer from any Urological Pelvic Pain Syndromes like Interstitial Cystitis and/or Chronic Prostatitis. However Positive Controls have a history of one of the following conditions:

Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome

Detailed Description:

Trans-MAPP Control participants will only need to complete one study visit to collect baseline data and biospecimens. Potential participants will be scheduled for an eligibility screening session. Following screening, potentially eligible participants will complete a baseline phenotyping session, and biospecimen collections, which together are expected to take approximately 2.5 hours to complete. Participants will be provided with breaks as needed during the clinic visit.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

The Trans-MAPP Control Study population will include adult participants, at least 18 years of age, with no urological chronic pelvic pain syndromes. These participants will fall into two categories: Healthy Controls and Positive Controls.

Criteria

The eligibility criteria for both healthy controls and positive controls are based on the same set of criteria for the Urologic Chronic Pelvic Pain Syndrome (UCPPS) participants in the Trans-MAPP EP Study, with exception of additional criteria to exclude chronic pelvic pain symptoms and criteria to identify the co-morbid syndromes for the positive controls. All entry criteria are shown below; those specific to either healthy or positive control participants are so indicated.

Inclusion Criteria:

Participants are eligible for the Trans-MAPP Control Protocol if they meet the following general and gender-specific criteria listed below:

Participant has signed and dated the appropriate Informed Consent document.

Agreed to participate in Trans-MAPP Control Study procedures;

Inclusion Criteria for Healthy Controls only

Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale.

Participant reports no chronic pain in the pelvic or bladder region, and reports chronic pain in no more than one other body region.

Participant reports no urological symptoms that have been evaluated, but are still present.

Inclusion Criteria for Positive Controls only:

1. Participant meets the validated criteria for one or more of the following conditions

Fibromyalgia (FM)

Irritable bowel syndrome (IBS)

Chronic fatigue syndrome (CFS)

Exclusion Criteria:

Individuals will not be eligible for enrollment in the Trans-MAPP Control Study if they meet any of the criteria:

Participant has an on-going symptomatic urethral stricture.

Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.

Participant has a history of cystitis caused by tuberculosis or radiation therapy or Cytoxan/cyclophosphamide therapy.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098292

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35205

United States, California

University of California, Los Angeles

Los Angeles, California, United States, 90073

Stanford University

Stanford, California, United States, 94304

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48106

United States, Missouri

Washington University

St Louis, Missouri, United States, 63110

United States, Washington

University of Washington

Seattle, Washington, United States, 98101

Sponsors and Collaborators

University of Pennsylvania

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

University of Colorado, Denver

Investigators

Study Chair:

J. Quentin Clemens, MD

University of Michigan

Study Director:

Christopher Mullens, PhD

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)